A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma

A Randomized Controlled Trial Testing a Skills-Based Program Called "A Toolkit for Optimal Recovery" Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries

The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.

Study Overview

• Status: Completed
• Conditions: Fracture; Musculoskeletal Injury
• Intervention / Treatment: Behavioral: The Toolkit for Optimal Recovery after Injury

Detailed Description

This is a pilot randomized feasibility trial of the mind body program Toolkit for Optimal Recovery versus usual medical care. The Toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. The primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. Secondarily, we report means and standard deviation and explore change in quantitative outcomes in the Toolkit compared to usual care.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of musculoskeletal injury in the past 1-2 months
• 18 years of age or older
• English fluency and literacy
• PCS OR, PASS score above median split

Exclusion Criteria:

• Major medical comorbidity expected to worsen in the next 6 months
• Comorbid chronic pain condition
• Antidepressant medication change in the past 6 months
• Secondary gains such as litigations or workers compensation procedures
• Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report)
• Unwilling or unable to use videoconferencing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Toolkit for Optimal Recovery after Injury; The Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability.	Behavioral: The Toolkit for Optimal Recovery after Injury; The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.; Other Names: ToR
NO_INTERVENTION: Usual Care; The Usual Care (UC) group will continue with their current medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized	0 Weeks
Satisfaction with ToR	3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.	4 weeks; 3 months
Acceptability	We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up	4 weeks; 3 months
Feasibility of outcome measures	We will report number of missing items and calculate reliability of outcome measures	0 weeks; 4 weeks; 3 months
Adherence to ToR	We will report number of participants who completed at least 3 out of 4 ToR sessions	4 weeks.
Adherence to homework	determined by number of homework logs returned	4 weeks
Therapist adherence survey	Items assessing whether the therapist taught each of the skills included in each of the 4 sessions	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Pain Catastrophizing Scale (PCS); items are summed to generate a total score; scores range from 0 to 52; higher scores indicate greater pain catastrophizing	0 Weeks, 4 Weeks, 3 Months
Pain Anxiety	Pain Anxiety Symptom Scale (PASS); items are summed to generate a total score; scores range from 0-100; higher sores indicate greater pain anxiety	0 Weeks, 4 Weeks, 3 Months
Depression	Center for Epidemiologic Studies Depression Scale (CESD); items are summed to generate a total score; scores range from 0 to 60; higher scores indicate greater depressive symptomatology	0 Weeks, 4 Weeks, 3 Months
Post Traumatic Stress Disorder	Post Traumatic Stress Disorder Checklist (PCL); items are summed to generate a total score; scores range from 17 to 85; higher scores indicate greater post traumatic stress	0 Weeks, 4 Weeks, 3 Months
Pain intensity	Numerical rating scale assessing pain form 0 to 10	0 Weeks, 4 Weeks, 3 Months
Physical Function	Short Musculoskeletal Function Assessment (SMFA); two scores are generated by summing items 1-34 for Function Index and 35-46 for Bothersome Index;	0 Weeks, 4 Weeks, 3 Months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Vranceanu AM, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): August 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Psychiatry; Psychology; Psychosocial; Mind-Body
• Other Study ID Numbers: 2014P001194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No